UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041941
Receipt No. R000044520
Scientific Title Distribution of heart rate variability in the upper grades of elementary school where school can be attended
Date of disclosure of the study information 2020/12/20
Last modified on 2020/09/29 (Ver. 1)

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Basic information
Public title Distribution of heart rate variability in the upper grades of elementary school who can attend school
Acronym NHRV test
Scientific Title Distribution of heart rate variability in the upper grades of elementary school where school can be attended
Scientific Title:Acronym NHRV test
Region
Japan

Condition
Condition Elementary school seniors who can attend school
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In children unable to attend school, changes in heart rate variability (HRV) over time can be observed . There are no reports of normal HRV values in children recorded using the types of HRV-measuring instruments currently available in Japan. In order to identify the abnormalities present in the HRV of children who refuse to attend school, data for normal values were gathered first.
Basic objectives2 Others
Basic objectives -Others It is already known that measured HRV values can change due to age, posture, and the presence or absence of heart failure, diabetes mellitus, and ischemic heart disease. In addition to the above-mentioned conditions, mood disorders are also reported to cause changes in HRV. Refusal to attend school in children is often associated with mood disorders. To identify HRV abnormalities in children who refuse to attend school, the distribution of HRV in children in the upper grades of elementary school who attend school was examined first.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes HRV is measured for elementary school seniors, CVRR obtained from SDNN and Mean from the time series analysis, VLF, LF, HF, Total Power, etc. from the frequency analysis by AR-Power Spectrum (Non-Detrend), naturally converted numerical values are added, and the average value and standard deviation are obtained.
Key secondary outcomes Using the results of frequency analysis, we confirm the conditions for obtaining a normal distribution for raw data and natural random conversion values.


Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit
12 years-old >
Gender Male and Female
Key inclusion criteria Elementary school children who can attend school and take regular classes

Key exclusion criteria Children who are unable to take regular classes and are only in the infirmary
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Ikeya
Organization Ikeya Clinic
Division name Dean
Zip code 436-0088
Address 2-10-14 Katsuragaoka,Kakegawa City,Shizuoka Pref.,Japan,436-0088
TEL 0537-22-0433
Email ikeya-25@fancy.ocn.ne.jp

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Ikeya
Organization Ikeya Clinic
Division name Dean
Zip code 436-0088
Address 2-10-14 Katsuragaoka,Kakegawa City,Shizuoka Pref.,Japan,436-0088
TEL 0537-22-0433
Homepage URL
Email ikeya-25@fancy.ocn.ne.jp

Sponsor
Institute Ikeya Clinic
Institute
Department

Funding Source
Organization Ikeya Clinic
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chutoen General Medical Center
Address 1-1 Shobugaike,Kakegawa City,Shizuoka Pref.,Japan,436-3555
Tel -0537-21-0555
Email rinshokenkyu@chutoen-hp.shizuoka.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 池谷医院（静岡県）

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 28
Results 
 HRV measurements were performed in 28 children with a mean age of 11 years at school using a portable electrocardiographic monitor.  The normality of the results and of the natural logarithms of the numerical values was examined. A normal distribution was only confirmed for CVRR and for HF subject to natural logarithm transformation.
Results date posted
2020 Year 09 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 12 Month 02 Day
Date of IRB
2019 Year 12 Month 02 Day
Anticipated trial start date
2020 Year 09 Month 14 Day
Last follow-up date
2020 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information HRV was measured in patients with dyslipidia at an average age of 60 years.
The mean values (and standard deviations) for HRV measured for 5 minutes subjected to natural logarithm transformation were as follows: the coefficient of variance of RR intervals (CVRR) was 1.13(0.35); the total power was 6.07 (0.90); the very low frequency (VLF) band was 5.66 (1.00); the low frequency (LF) band was 4.16 (0.90); and the high frequency (HF) band was 3.99 (0.90). All test items showed normality distribution.



Management information
Registered date
2020 Year 09 Month 29 Day
Last modified on
2020 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044520